MINOCYCLINE HYDROCHLORIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)

Предлага се от:

Cardinal Health

INN (Международно Name):

MINOCYCLINE HYDROCHLORIDE

Композиция:

MINOCYCLINE 50 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
CARDINAL HEALTH
----------
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
3165
7300
3167
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of minocycline
hydrochloride capsules and other antibacterial drugs, minocycline
hydrochloride capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Minocycline hydrochloride, is a semisynthetic derivative of
tetracycline, 4,7-Bis(dimethylamino)-
1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride.
Its structural formula is:
C
H N O •HCl M.W. 493.94
Minocycline hydrochloride capsules, USP for oral administration
contain minocycline hydrochloride
equivalent to 50 mg, 75 mg, or 100 mg of minocycline.
INACTIVE INGREDIENTS
_Drug Product:_ corn starch and magnesium stearate. _Capsule Shell:_
gelatin and titanium dioxide. In
addition, the 100 mg capsule shells contain, D&C Red #28, FD&C Blue
#1, FD&C Red #40, and red
iron oxide; the 75 mg capsule shells contain black iron oxide; and the
50 mg capsule shells contain
D&C Red #33, FD&C Red #3, and FD&C Yellow #6. _Printing Ink: _black
iron oxide and shellac. In
addition, the 50 mg and 100 mg ink contains D&C Yellow #10, FD&C Blue
#1, FD&C Blue #2, FD&C
Red #40, propylene glycol, and strong ammonia solution and the 75 mg
ink contains antifoam DC 1510,
industrial methylated spirit 74 OP BP, and soya lecithin.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride capsules, 100
mg administered to 18 normal
fasting adult volunteers, maximum serum concentrations were attained
in 1 to 4 hours (average 2.1
hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The
serum half-life in the normal
volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).
When minocycline hydrochloride capsules were given concomitantly with
a high-fat meal, which
included dairy products, the e